Neoadjuvant Taxotere
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
The purposes of this study are to better understand how Taxotere causes tumors to become smaller and to find out how effective Taxotere is in treating the type of breast cancer that you have.
Key facts
- Study ID
- NCT00206505
- Run by
- Baylor Breast Care Center
- People needed
- 40
- Starts
- 1999-01-01
- Expected to finish
- 2004-07-01
- Last updated by the study team
- 2011-11-17
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 1. All patients must be female. 2. Signed informed consent. 3. Locally advanced breast cancers or primary breast cancers with concomitant metastatic disease are eligible. Locally advanced cancers must be of clinical and/or radiologic size >4 cm and/or are deemed surgically inoperable. 4. Negative serum pregnancy test within 7 days of starting study, if of child-bearing potential. 5. Adequate bone marrow function: Hematocrit of greater than 30%, total neutrophil count must be >1.5 x 10(9)/L and platelets of >100 x 10(9)/L prior to the start of any cycle. 6. Kidney function tests - within 1.5 times of the institution's upper limit of normal. Total serum bilirubin within upper limit of normal. 7. Electrocardiogram showing no acute ischemic changes. 8. Performance status (WHO scale) <2 (Appendix I) and life expectancy >1 year. 9. Age > 18 years. 10. No brain and/or leptomeningeal disease. 11. No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
You may not qualify if…
- 1. Pregnancy or unwillingness to use reliable contraceptive method in women of child-bearing potential. 2. Severe underlying chronic illness or disease. 3. Peripheral neuropathy - grade 2 or greater. 4. Patients on other investigational drugs while on study will be excluded. 5. Severe or uncontrolled hypertension, history of congestive heart failure, or severe coronary arterial disease.
Where it is running
- Baylor Breast Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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